510(k) K002902 ยท MSD Catheter, Hemodialysis, Implanted
TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
| Applicant | The Kendall Company, Mansfield MA, US |
| Decision | Substantially Equivalent, Apr 9, 2001 |
| Received | Sep 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002902
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2003 | Tyco Healthcare/Kendall Tandem-Cath Hemodialysis Cuffed Catheter with side holes
10 Fr 19 cm Arterial Cuff/22cm Venous Cuff
Code #: 8888-219226 Terminated |
None listed | |
| Apr 18, 2003 | Tyco Healthcare/Kendall Tandem-Cath Hemodialysis Cuffed Catheter with side holes
10 Fr 23 cm Arterial Cuff/26cm Venous Cuff
Code #: 8888-223266 Terminated |
None listed | |
| Apr 18, 2003 | Tyco Healthcare/Kendall Tandem-Cath Hemodialysis Cuffed Catheter with side holes
10 Fr 28 cm Arterial Cuff/31 cm Venous Cuff
Code #: 8888-228316 Terminated |
None listed | |
| Apr 18, 2003 | Tyco Healthcare/Kendall Tandem-Cath Hemodialysis Cuffed Catheter with no side holes
10 Fr 23 cm Arterial Cuff/26cm Venous Cuff
Code #: 8888-223260 Terminated |
None listed | |
| Apr 18, 2003 | Tyco Healthcare/Kendall Tandem-Cath Hemodialysis Cuffed Catheter with no side holes
10 Fr 28 cm Arterial Cuff/31cm Venous Cuff
Code #: 8888-228310 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.